常用藥學(xué)中英文詞匯對(duì)照

1、生產(chǎn)工藝常用詞匯:中文英文硫酸氫鈉中性硼玻璃安瓿瓶安瓿瓶清洗Kan amyci n sulfate sodium bisulfate sodium citrate Sulfuric acid solutiNeutral borosilicate glass ampoule Ampoule washi ng安瓿瓶火菌除熱源配料過濾灌封Ampoule depyroge natiBatch ingFiltrati onFilli ng and seali sterilizati onand火菌和檢漏測試燈檢貼簽和包裝 升溫段傳送帶壓差時(shí)間間隔 Sterilization and leakage te

2、st Visual / Lamp in spect ion Labeli ng and packag ing Critical Process Parameter heati ng sect ioncon veyor belt Differen tial pressure Time in tervalPore size of filter過濾壓力灌 裝 量 緩沖罐灌裝前充氮保護(hù)真空檢漏測試 內(nèi)包材Filtrati on pressure Filli ng volume buffer tankpre-fill ing n itroge n flush post-fillingnitrogenov

3、erlay Vacuum leaktestPrimary packaging materialProcess in structio nLivzonGroupFuzhouFux Pharmaceutical Co.Ltd.HunanErkangPharmaceuticalCo.,HunanHuariPharmaceuticalCo.,LtdGuangzhouChemicalReagentFactory ZhuhaiDaLinWanIndustrialGasCo.,LtdSCHOTT Glass Tech nologies (Suzhou)Co. Ltdquality specificati C

4、irculati on water Rotati ngspeedQC 常用英文詞匯中文外觀溶液顏色 鑒別含量標(biāo) 小 量 無菌薄膜過濾法內(nèi)毒素英文Physical attributes Appeara nee Particulate matter Soluti on colorIdentificatiretentiontime AssayRelated substa nee labeled amount Visible particles SterilityMembrane filtration Bacterial en dotox insIn itial bioburde n stirring

5、 uniformity ashy toppoin ted endbubble head, flat head, broke n ampoule, crooked ampoule, empty ampoule;中文中文英文藥品生產(chǎn)質(zhì)量管理規(guī)范GMP: GoodManufacturingPractice國家食品與藥品監(jiān)督管理局State Food and DrugAdministration總則Gen eral Provisi ons制劑preparati on原料藥API: Active PharmaceuticalIn gredie nt成品finishedgoods工序process機(jī)構(gòu)與人

6、員orga ni zatio nandpers onnel專業(yè)知識(shí)professi onalknowledge生產(chǎn)經(jīng)驗(yàn)producti onexperie nee組織能力orga ni zati onalskill技術(shù)人員tech ni calstaff實(shí)施藥品生產(chǎn)質(zhì)里官理質(zhì)里檢驗(yàn)impleme ntati onpharmaceuticalmanu facturi quality man ageme ntqualityin spect ion專業(yè)技術(shù)培訓(xùn)professionalandtechnicaltraining基礎(chǔ)理論知識(shí)basictheoreticalknowledge高生物活性 咼毒

7、性污染考核評(píng)估 生產(chǎn)環(huán)境昆蟲潔凈室（區(qū)光滑無裂縫耐受消毒practical operati on highlypote nthigh toxicitycon tam in atiassessme ntbuildi ngs and facilities producti onen viro clean air levelin sectclean room(area) smoothno cracksno particle shedding tolera needis in fecti on無 菌 弧形儲(chǔ) 存 區(qū) 設(shè)備物料待 驗(yàn) 品 管道公用設(shè)施照明照度應(yīng)急，緊急情況凈化sterile juncti

8、on, joint arcdust store area producti on scale equipme nt materialin termediate product quara nti ned material cross-c on tam in ati on pipeli neutilities of public servicelighting illumi natio emerge ncypurificati on, clea n微生物微生物學(xué)監(jiān)測記錄micro-orga nism, mon itori ng recordmicrobiology,microbiologic天棚

9、天花板ceili ng, roof密封seal溫度地漏Static Differential temperatureRH: Relative Humidity floor dra inerPressure分裝室相對(duì)負(fù)壓廢氣separati ngroom,filli ng roomrelativen egativewaste gas, exhausted airB避孕藥品激 素 類 包裝微粒脫毒前后3 -Lactams structure drug con traceptiveshorm oneanti-tumor,on Radiopharmaceuticals pack ing, packag

10、e recycli ngparticles radiati on bacteria viruscellPre-detoxificationand postdetoxification活疫苗與滅活疫苗人血液制品預(yù)防制品灌裝active vacci ne/in activated blood productspreve nti onproductsfilli ngvacc ine中 藥 前處理提 取 濃縮Chin esetraditipretreatme nt extractio nconcen trati onmedici nes炮制viscera of animal, organ of ani

11、mal con coctedven tilatio n smoke removal dust removal降溫設(shè)施取樣稱量室temperature-reduc ingscree ning slici ng grindingcompressed air n oble gas sampli ng weighi ng roomestablishment,cooli ng中藥標(biāo)本Chinese herbal sample, exemplar of TCM檢定鑒定verificati on,ide ntificati on同位素Isotope設(shè)備equipme nt選型吸附model/typesele

12、ct an ticorrosi onadsorpti on,absorptio n潤滑劑，潤滑lubrica nt, lubricate冷卻劑coola nt流向flow direct ion純化水PW: Purified Water注射用水WFI: Water for Injection滋生breed ing儲(chǔ)罐tank死角n eglectedporti on盲管bli nd pipe纖維fiber疏水性hydrophobicity儀表in strume ntati on量具measuri ng tool衡器weigh ingin strume nt精密度不合格物 料 購 買 發(fā) 放 產(chǎn) 地

13、 固 體 液 體 易燃標(biāo)簽間隔時(shí)間precisi on maintenance disqualified material purchas ing releas ing origi nsolid liquid volatilenet medicine, net n arcotics psychotropic drug combustibleexplosive accepta nee in structi on labelhygie ne workshop time in terval清潔劑消毒劑廢棄物更衣室工作服，顆粒性物質(zhì)耐藥菌株傳染病皮膚病驗(yàn) 證 確 認(rèn) 安 裝 運(yùn) 行 性 能 原輔料文

14、件 投 訴 報(bào) 廢 品 名 處方技術(shù)參數(shù)deterge nt dis in fectawastescha ngingwork clothes granu lesdrug-resistantinfectiousdisease dermatosisverificati on, validati on qualificati onin stallati on running operati on performa neeraw material and excipie nt docume ntcomplai nt rejectproduct n ameprescripti on,tech ni ca

15、lparameter容 器 申 請(qǐng) 穩(wěn)定性起草生產(chǎn)管理container applicati on stability draftproducti onman ageme nt,manu facturi ngcontrol.混 淆 噴 霧 合格證清場質(zhì)里官理內(nèi) 控 滴定液培養(yǎng)基有效期產(chǎn)品銷售與收回mix-up spray certificate cleara neequality man ageme ntinternal con trol titra ntmediumvalidity, expiry date, shelf product sales and recall投訴與不良反應(yīng)報(bào)告自

16、檢 附 則 平 衡 飲用水compla ints and adverse react ion self- in spect ionappe ndix bala nee drinking report蒸餾法離子交換法反滲透法附加劑添加劑distillatio n ion exchangeRO: Reverse Osmosis additives滯留批組分， 組成stra nded batch, lot comp onentresort無纖維脫落的過濾器活性成份非活性成份non-fiber-releas Active In gredie ntIn activein gredie ntfilter中

17、間產(chǎn)品批號(hào)藥用物料in termediate batch nu mber medicated product藥用預(yù)混合料medicated premix質(zhì)量控制部門理論產(chǎn)量實(shí)際產(chǎn)量比率驗(yàn)收標(biāo)準(zhǔn)可接受標(biāo)準(zhǔn)Qualitycontrol Theoretical yield Actual yield Perce ntage, Accepta nee criteriadepartme nt代表性樣品微粒狀的Represe ntative sample particulate污染物石 棉 診 斷 緩解化學(xué)變化con tamasbestos diag no sis mitigationchemicalcha

18、 nge組分in gredie 制備fabricate復(fù)合compo und混合ble nd加工process ingcomp onent preparati on濃度單位劑量藥品包裝容器密圭寸件， 效價(jià)concen trati on unit dosedrug product containers closuretiter purity stre 監(jiān)督實(shí)驗(yàn)室supervise, laboratorymon itor無菌操作層流asepticoperati on,sterile operatio lam inar flow湍流空氣過濾空氣加熱預(yù)過濾器turbule nt air filtrat

19、ion air heating Pre-filterair flow排氣系統(tǒng)垃圾有機(jī)廢料殺 鼠 劑 殺昆蟲劑殺真菌劑熏 烝 劑 去垢劑exhaust system plumbi ng sewagerefuse air drier trashorga nicrode nticidesin secticides fun gicidesfumigati ngreage clea ning age nts消毒劑滂沱劑san itiz ing lubrica ntage nts自動(dòng)化設(shè)備、機(jī)械化設(shè)備和電子設(shè)備微型膠卷automatic, mechanical, or electronic tmicrof

20、ilmequipmen注 射 劑 火菌設(shè)備injectio nsterilizatio nequipme nt無菌取樣技術(shù)顯微鏡熱源， 偏差鑒別片 劑 膠 囊 顆粒劑澄 明 度 返工發(fā)放aseptic sampli ng microscopepyroge n,en dotox deviati oncha nge con trol charge-i nitem code identify tablet capsule granuledissoluti onclarityisolationreprocess ingissua nee, releasetech niq ues非處方藥處方藥OTC:

21、over-the-counter prescripti onmedici 保險(xiǎn)包裝tamper-resista ntpackage順勢(shì)治療 入庫變 質(zhì) 準(zhǔn)確性靈敏性特異性hard gelatin homeopathic warehous ing deteriorate accuracysen sitivityspecificity重復(fù)性變應(yīng)原提取物reproducibility, allerge nicrepeatability眼膏粗糙或磨蝕物質(zhì)ophthalmicoin tme nt harsh or abrasive substances控釋制劑controlled-releasedosage form實(shí)驗(yàn)動(dòng)物供 應(yīng) 商 光譜laboratory supplier spectrumani mals測量單位試劑取代units of measure con vers ion factors reage ntplacebo